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Spinal Cord Injury Collaborative Care Study (SCI-Care)

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Collaborative Care
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Chronic Pain, Mood, Physical Activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older
  • diagnosis of traumatic spinal cord injury by medical record review
  • receives primary SCI care from a provider at the University of Washington or Harborview Medical Center's Rehabilitation Outpatient Clinic
  • positive screening for pain related to SCI diagnosis and/or
  • positive screening for low mood and/or
  • negative screening for physical activity levels
  • able to speak and understand English

Exclusion Criteria:

  • psychiatric condition that would interfere with participation
  • major surgery in the next 8 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Usual Care

    Intervention

    Arm Description

    No intervention, usual care

    Collaborative care with Health Care Assistant

    Outcomes

    Primary Outcome Measures

    Change in Quality of Life
    Quality of Life is assessed via telephone interviews at baseline and 4 months.

    Secondary Outcome Measures

    Change in Pain
    Pain is assessed via telephone interview at baseline, 4 months, and 8 months.
    Change in Mood
    Mood assessed via telephone interviews at baseline, 4 months, and 8 months.
    Change in Physical Activity
    Physical activity is assess via telephone interview at baseline, 4 months, and 8 months.
    Change in Quality of Life
    Change in QOL from baseline to 8 months will be compared between groups
    Adverse events
    The number of cases with serious or non-serious adverse events in the two arms

    Full Information

    First Posted
    December 26, 2013
    Last Updated
    February 23, 2019
    Sponsor
    University of Washington
    Collaborators
    U.S. Department of Education
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02026167
    Brief Title
    Spinal Cord Injury Collaborative Care Study
    Acronym
    SCI-Care
    Official Title
    SCI-CARE (Northwest Regional Spinal Cord Injury Site Specific Project)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2012 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington
    Collaborators
    U.S. Department of Education

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study is to test the effectiveness of a collaborative care approach to improving outpatient treatment for inactivity, chronic pain and depression as a way of improving overall Quality of Life for patients with SCI.
    Detailed Description
    Individuals with SCI were treated by a care manager who worked in collaboration with the participant's physician to decrease pain, decrease depression symptoms, and/or to increase physical activity. This was done by collaborating on current treatments to make sure that they are being as effective as possible and by providing non-pharmacological treatments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injury
    Keywords
    Chronic Pain, Mood, Physical Activity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    174 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    No intervention, usual care
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Collaborative care with Health Care Assistant
    Intervention Type
    Behavioral
    Intervention Name(s)
    Collaborative Care
    Intervention Description
    Addition of a Health Care Assistant to treatment team, case review by expert panel of supervisors, non-medical interventions
    Primary Outcome Measure Information:
    Title
    Change in Quality of Life
    Description
    Quality of Life is assessed via telephone interviews at baseline and 4 months.
    Time Frame
    Baseline, 4 months
    Secondary Outcome Measure Information:
    Title
    Change in Pain
    Description
    Pain is assessed via telephone interview at baseline, 4 months, and 8 months.
    Time Frame
    Baseline, 4 months, 8 months
    Title
    Change in Mood
    Description
    Mood assessed via telephone interviews at baseline, 4 months, and 8 months.
    Time Frame
    Baseline, 4 months, 8 months.
    Title
    Change in Physical Activity
    Description
    Physical activity is assess via telephone interview at baseline, 4 months, and 8 months.
    Time Frame
    Baseline, 4 months, 8 months
    Title
    Change in Quality of Life
    Description
    Change in QOL from baseline to 8 months will be compared between groups
    Time Frame
    Baseline, 8 months
    Title
    Adverse events
    Description
    The number of cases with serious or non-serious adverse events in the two arms
    Time Frame
    baseline to 4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older diagnosis of traumatic spinal cord injury by medical record review receives primary SCI care from a provider at the University of Washington or Harborview Medical Center's Rehabilitation Outpatient Clinic positive screening for pain related to SCI diagnosis and/or positive screening for low mood and/or negative screening for physical activity levels able to speak and understand English Exclusion Criteria: psychiatric condition that would interfere with participation major surgery in the next 8 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles H Bombardier, Ph.D.
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    http://sci.washington.edu/scicare/
    Description
    General study information on the Northwest Regional SCI System website

    Learn more about this trial

    Spinal Cord Injury Collaborative Care Study

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